WO2019064090A1 - Nouvelle composition pharmaceutique comprenant de l'acide méfénamique et d'autres analgésiques - Google Patents

Nouvelle composition pharmaceutique comprenant de l'acide méfénamique et d'autres analgésiques Download PDF

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Publication number
WO2019064090A1
WO2019064090A1 PCT/IB2018/056706 IB2018056706W WO2019064090A1 WO 2019064090 A1 WO2019064090 A1 WO 2019064090A1 IB 2018056706 W IB2018056706 W IB 2018056706W WO 2019064090 A1 WO2019064090 A1 WO 2019064090A1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
mefenamic acid
analgesic
salt
composition according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2018/056706
Other languages
English (en)
Inventor
Sivakumar Venkata BOBBA
Bhimrao Jadhav
Dhananjay Shinde
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zenvision Pharma LLP
Original Assignee
Zenvision Pharma LLP
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zenvision Pharma LLP filed Critical Zenvision Pharma LLP
Publication of WO2019064090A1 publication Critical patent/WO2019064090A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil

Definitions

  • Dysmenorrhea is the most commonly reported menstrual disorder. More than one half of women who menstruate have some pain for 1-2 days each month. Pain associated with menstruation is called dysmenorrhea. There are two types of dysmenorrhea i.e. primary dysmenorrhea and secondary dysmenorrhea. Primary dysmenorrhea is pain that comes from having a menstrual period or menstrual cramps. Primary dysmenorrhea is the most common type of dysmenorrhea, affecting more than 50% of women, and quite severe in about 15%. Primary dysmenorrhea is more likely to affect girls during adolescence.
  • Secondary dysmenorrhea is pain that is caused by a disorder in the woman's reproductive organs, such as endometriosis, adenomyosis, uterine fibroids, or infection. Secondary dysmenorrhea is more likely to affect women during adulthood. Treatment of dysmenorrhea relieves pain or symptoms either by affecting the physiological mechanisms behind menstrual pain or by relieving symptoms. In clinical practice, nonsteroidal anti-inflammatory drugs (NSAIDs) are considered the first-line therapeutic option for managing pain associated with dysmenorrhea. Also other analgesics, oral contraceptives are used in the treatment of dysmenorrhea.
  • NSAIDs nonsteroidal anti-inflammatory drugs
  • a first aspect of the present invention is to provide novel pharmaceutical composition comprising mefenamic acid and an other analgesic; wherein mefenamic acid is in the modified release form and the other analgesic is in the immediate release form or vice versa.
  • Another aspect of the present invention is to provide novel pharmaceutical composition comprising mefenamic acid and an other analgesic along with one or more pharmaceutically acceptable excipient; wherein mefenamic acid is in the modified release form and other analgesic is in the immediate release form or vice versa.
  • in another aspect of the present invention is to provide novel pharmaceutical composition comprising mefenamic acid and Naproxen or salt thereof; wherein mefenamic acid is in the modified release form and Naproxen or salt thereof is in the immediate release form or vice versa.
  • the present invention relates to novel pharmaceutical composition comprising mefenamic acid and an other analgesic for the treatment of dysmenorrhea.
  • novel pharmaceutical composition according to the present invention may be preferably in the form of tablet or capsule or sachet.
  • binder examples include but not limited to ethyl cellulose, gelatin, hydroxyethyl cellulose, carboxymethyl cellulose sodium, hydroxymethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium aluminium silicate, maltodextrin, methyl cellulose, povidone, starch or mixture thereof.
  • the binder is present in the composition in an amount of about 0.005% to 10% based on the total weight of the composition; preferably in an amount of about 0.01% to 5% based on the total weight of the composition.
  • lubricant examples include but not limited calcium stearate, magnesium stearate, polyethylene glycol, sodium benzoate, potassium benzoate, sodium lauryl sulphate, talc, stearic acid, zinc stearate or mixture thereof.
  • the lubricant is present in the composition in an amount of about 0.05% to 5% based on the total weight of the composition; preferably in an amount of about 0.1% to 2% based on the total weight of the composition.
  • novel pharmaceutical composition of the present invention may be in the form of bilayer tablet wherein one layer is of immediate release of other analgesic preferably naproxen or salt thereof and other layer is of modified release mefenamic acid.
  • novel pharmaceutical composition of the mefenamic acid and other analgesic preferably Naproxen or salt thereof according to present invention provides flexibility in dosage administration in the treatment of acute as well as chronic pain of dysmenorrhea.
  • Step 2 mixtures were granulated in granulator using binder solution from step 3.
  • Step 3 wet granules were passed through #8 sieve and dried in suitable dryer till desired LOD is achieved.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une nouvelle composition pharmaceutique comprenant de l'acide méfénamique et un autre analgésique ou un sel de celui-ci. La nouvelle composition selon la présente invention permet une libération modifiée d'acide méfénamique et une libération immédiate d'un autre analgésique dans le traitement de la dysménorrhée.
PCT/IB2018/056706 2017-09-28 2018-09-03 Nouvelle composition pharmaceutique comprenant de l'acide méfénamique et d'autres analgésiques Ceased WO2019064090A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201721034457 2017-09-28
IN201721034457 2017-09-28

Publications (1)

Publication Number Publication Date
WO2019064090A1 true WO2019064090A1 (fr) 2019-04-04

Family

ID=65902273

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2018/056706 Ceased WO2019064090A1 (fr) 2017-09-28 2018-09-03 Nouvelle composition pharmaceutique comprenant de l'acide méfénamique et d'autres analgésiques

Country Status (1)

Country Link
WO (1) WO2019064090A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6929805B2 (en) * 1997-04-15 2005-08-16 Bayer Aktiengesellschaft Analgesic combination

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6929805B2 (en) * 1997-04-15 2005-08-16 Bayer Aktiengesellschaft Analgesic combination

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